A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of EDP-978 in Healthy Adults

Part of paid clinical trials in San Antonio, Texas.

Sponsor
Enanta Pharmaceuticals, Inc
Study ID
NCT07540910
Phase
PHASE1
Status
Recruiting
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Conditions

  • Chronic Inducible Urticaria
  • Chronic Spontaneous Urticaria

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • EDP-978 — DRUG
    Oral administration
  • Placebo — DRUG
    Placebo to match EDP-978, oral administration

Study Details

This study is a randomized, double-blind, sponsor-open, placebo-controlled study. It will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered single and multiple doses of EDP-978 in healthy adult subjects.

Key Dates

Start date
Apr 1, 2026
Status verified
Apr 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
98 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: EDP-978 SAD Cohorts
    EDP-978 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5, Dose 6 and Dose 7, orally daily in one single administration
  • Experimental: EDP-978 MAD Cohorts
    EDP-978 Dose 1, Dose 2, Dose 3, Dose 4 and Dose 5 orally, once daily for 14 days
  • Placebo Comparator: EDP-978 SAD Placebo Cohorts
    Matching placebo, orally, once daily in one single administration
  • Placebo Comparator: EDP-978 MAD Placebo Cohorts
    Matching placebo, orally, once daily for 14 days

Primary Outcome Measure

Safety measured by adverse events [ Time Frame: Up to 8 Days in SAD Cohorts ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
ICON Early PhaseSan AntonioTexas78209
Shannon Kirk
[email protected]
Shannon
[email protected]
9134102258
Cassandra Key, MD (PRINCIPAL_INVESTIGATOR)

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By research site
ICON Early Phase· San Antonio, TX

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